MULTI-CHANNEL COMPRESSION BTE (SD)

Hearing Aid, Air Conduction

MIRACLE-EAR, INC.

The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Multi-channel Compression Bte (sd).

Pre-market Notification Details

Device IDK970262
510k NumberK970262
Device Name:MULTI-CHANNEL COMPRESSION BTE (SD)
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
ContactMelanie Raska
CorrespondentMelanie Raska
MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-23
Decision Date1997-03-31
Summary:summary

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